BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL TRIO 3MM CURVE TIP 35CM

    MDR report key: 1760921 · Received July 19, 2010

    Report

    Report Number
    3005075853-2010-04009
    Event Type
    Injury
    Date Received
    July 19, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) = AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE SURGEON STATED THE DEVICE ACTIVATED ON ITS OWN DURING THE PROCEDURE AND BURNED A HOLE IN THE PATIENT'S BOWEL. IT IS NOT KNOWN AT THIS TIME WHAT DEGREE THE BURN WAS. THE TROCAR INSERTION SITE HAD TO BE MADE LARGER AND THE BOWEL WAS PULLED OUT TO REPAIR. THE SURGEON THEN USED A SECOND LIKE DEVICE TO CONTINUE WITH THE PROCEDURE. THE EXTENDED TIME WAS NOT REPORTED. . THE PATIENT IS STABLE. ADDITIONAL INFORMATION RECEIVED: SURGEON SAYS HE WAS NOT USING IT AS A GRASPER, WAS NOT NEAR BOWEL, AND IT "WENT OFF". SURGEON HEARD BEEPING, INDICATING THAT THE ENSEAL ACTIVATED. ONCE THE ACTIVATION SOUND WAS HEARD, THEY MOVED CAMERA TO WHERE ENSEAL WAS (REP BELIEVES THAT THERE WERE EXCHANGING INSTRUMENTS OUT WHEN THIS OCCURRED) AS THE ENSEAL WAS NOT BEING USED AT THAT TIME. WHEN THEY MOVED THE CAMERA THEY SAW A DEFECT (A BURN) ON THE BOWEL. A COLO-RECTAL SURGEON WAS CALLED IN WHO OVERSEWED THE BOWEL. PATIENT IS DOING WELL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING ADMITTED IN THE HOSPITAL FOR SEVERAL HOURS DUE TO A LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT HE WAS TREATING HIS HIGH GLUCOSE AND TOOK TOO MUCH INSULIN. THE CUSTOMER ALSO REPORTED THAT THE BATTERY CAP HAD POPPED OFF, AND IT DID NOT CHARGE THE TRANSMITTER. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO 3MM CURVE TIP 35CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK G4TO56

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention GENERATOR